F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

Bone Metastases Clinical Trial

Official title:

18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00882609
• Other study ID #: AMI-2008-01
• Status: Recruiting
• Phase: Phase 3
• First received: April 15, 2009
• Last updated: November 28, 2012
• Start date: January 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: American College of Radiology - Image Metrix
• Contact: Johannes Czernin, MD
• Phone: (310) 983-1443
• Email: JCzernin[@]mednet.ucla.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.

Description:

The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria.

Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site.

The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)

• Patient or patient's legally acceptable representative cognitively provides written informed consent

• Patients without known bone metastases who are newly diagnosed with = stage 3 breast cancer, = stage 3 lung cancer, or = stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer

• Patient is scheduled to undergo a conventional bone scan

• Patient is capable of complying with study procedures

• Patient is able to remain still for duration of imaging procedure (about one hour)

• Patient may have had a prior PET or PET/CT scan for staging/restaging.

Exclusion Criteria:

• Patient is < 18 years old at the time of the drug administration

• Patient is pregnant or nursing;

• testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration

• obtaining surgical history (e.g., tubal ligation or hysterectomy)

• confirming the subject is post menopausal, with a minimum 1 year without menses

• Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data

• Patient has known bone metastases

• Patient has previously received [18F]NaF in the last thirty days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.

Locations

Country	Name	City	State
Australia	Peter MacCallum	Melbourne	Victoria
Austria	PET-CT Linz - St. Vicent's Hospital	Linz
Portugal	Hospitais da Universidade de Coimbra	Coimbra
Switzerland	University Hospital Zurich	Zurich
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Silicon Valley Imaging	Freemont	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedar-Sinai Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	VA West Los Angles Medical Center	Los Angeles	California
United States	New York Presbyterian Weill Cornell	New York	New York
United States	John Cochran Veterans Administration	Saint Louis	Missouri
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Utah School of Medicine	Salt Lake	Utah
United States	SouthCoast Imaging Center	Savannah	Georgia
United States	Scottsdale Medical Imaging	Scottsdale	Arizona
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology - Image Metrix	World Molecular Imaging Society

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning	The primary endpoint will be an analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.	6 Months	No